Actively Recruiting
Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial
Led by University of Washington · Updated on 2026-04-22
22
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well pirtobrutinib and mosunetuzumab work in treating patients with grade 1-3a follicular lymphoma (FL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Pirtobrutinib, a type of tyrosine kinase inhibitor, works by blocking the action of the Bruton tyrosine kinase (BTK) protein. The BTK protein signals cancer cells to multiply, and blocking it may help keep cancer cells from growing. It could also improve T cell fitness and decrease inflammation, therefore, may improve the efficacy and safety of T cell-based therapies, such as mosunetuzumab. Mosunetuzumab is a bispecific antibody that binds both T cells and the lymphoma cancer cells and harnesses T cells to interfere with the ability of cancer cells to grow and spread. Giving pirtobrutinib and mosunetuzumab together may kill more tumor cells in patients with relapsed or refractory grade 1-3a FL and potentially decreases some side effects of mosunetuzumab which are related to T cells being activated (e.g., cytokine release syndrome).
CONDITIONS
Official Title
Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Age 18 years or older
- ECOG performance status of 0 or 1
- Histologically confirmed grade 1-3a follicular lymphoma
- Relapsed or refractory after at least two prior systemic therapies including anti-CD20 therapy
- Prior treatment-related side effects recovered to grade 1 or less except alopecia and grade 2 peripheral neuropathy
- At least one measurable lesion (nodal 1.5 cm, extranodal 1.0 cm) within 6 weeks by PET/CT or approved imaging
- Liver enzymes (AST and ALT) 3 times upper limit of normal
- Total bilirubin 1.5 times upper limit of normal, or up to 3 times with liver involvement or Gilbert syndrome
- Platelet count 75,000/mm3 without recent transfusion
- Absolute neutrophil count 1000/mm3 without growth factors
- Hemoglobin 10 g/dL without recent transfusion
- Patients with marrow involvement or cytopenia may enroll if platelets 50,000/mm3, neutrophils 750/mm3, hemoglobin 7.5 g/dL as confirmed by investigator
- Coagulation tests (aPTT/PT/INR) 1.5 times upper limit of normal
- Creatinine clearance 30 mL/min
- Negative pregnancy test for women of childbearing potential
- Fertile males and women of childbearing potential willing to use effective contraception during and after treatment
You will not qualify if you...
- Disease progression within 6 months of prior BTK inhibitor therapy (BTKi refractory)
- Prior treatment with pirtobrutinib
- Disease exposed to CD3 T-cell engager unless remission lasted at least 24 months
- Use of monoclonal antibodies, radioimmunoconjugates, or antibody-drug conjugates within 4 weeks before starting treatment
- Use of T cell-targeting immunotherapies within 12 weeks or 5 half-lives before treatment
- Chemotherapy or other anti-cancer treatments within 4 weeks or 5 half-lives before treatment
- Radiotherapy within 2 weeks before treatment unless measurable lesion outside radiation field
- Stem cell transplant or CAR-T therapy within 60 days or with ongoing complications
- Prior solid organ transplant
- Unable to swallow oral medications
- History of bleeding disorders or major bleeding on prior BTKi
- Significant malabsorption or gastrointestinal conditions affecting drug absorption
- History of autoimmune diseases including myocarditis, pneumonitis, myasthenia gravis, lupus, rheumatoid arthritis, and others
- History of macrophage activation syndrome/HLH
- History of progressive multifocal leukoencephalopathy
- Severe allergic reactions to monoclonal antibodies or BTKi
- Other malignancies unless in remission for at least 2 years or non-invasive cancers as specified
- Current or past central nervous system lymphoma or certain CNS diseases
- Significant cardiovascular disease or uncontrolled arrhythmias
- Active pulmonary disease
- Active uncontrolled infections or major infections within 4 weeks before treatment
- Active hepatitis B or C infection
- Positive HIV test
- Need for therapeutic anticoagulation with warfarin or vitamin K antagonists
- Pregnant or breastfeeding
- Live vaccination within 28 days before treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Mengyang Di, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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